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The NeoMed Enteral Only Extension Set is intended for use as an extension set for nasogastric/oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors which help mitigate the risk of accidental misconnection with an I.V. system to the enteral system or the enteral system to an I.V. system.

The NeoMed Enteral Only Extension Set is a sterile disposable for single patient use only device designed to help minimize the potential for inadvertent delivery of enteral feedings through the intravenous route. The device consists of flexible PVC tubing designed to connect existing feeding tubes (nasogastric, oralgastric, etc) to various delivery systems in including pumps and syringes. The set consists of tubing with an enteral connector (catheter tip) and an oral syringe connector not compatible with IV tubing or stopcocks. The NeoMed Enteral Only Extension Set provides an orange stripe for easy quick identification of enteral feeding lines as well as an "Enteral Only" tag and slide clamp to provide the additional safety assurance for connection errors.

The provided text describes the NeoMed Enteral Only Extension Set, a Class II medical device. However, it does not contain the information needed to fill out a table of acceptance criteria, detailed device performance, or a comprehensive study description as requested.

The document is a 510(k) summary, which focuses on establishing substantial equivalence to a predicate device rather than presenting detailed clinical study results or specific performance criteria with numerical targets.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Table: The document states that "Design verification functional test results demonstrate that the NeoMed Enteral Only Extension Set performs its intended use." It then lists the types of tests conducted: "mechanical: tensile, strain, elongation and physical/properties testing comprised of dimensional verification, flow rate, and hub compatibility. Packaging challenges for package integrity and product stability were conducted with aging studies. All materials have been evaluated in accordance with ISO 10993-1: Biological Evaluation of Medical Devices – part 1: Evaluation and Testing and the three tests conducted - cytotoxicity, sensitization, and irritation pass."

*Crucially, the specific quantitative acceptance criteria (e.g., "tensile strength > X N") and the numerical results (e.g., "tensile strength = Y N") for these tests are NOT provided in this document. The document only states that the tests were conducted and "pass" or "demonstrate that the device performs its intended use."

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified. The document refers to "functional tests conducted" but does not give the number of units tested for each type of performance test.
• Data Provenance: Not specified (e.g., country of origin of data). The testing appears to be internal validation by the manufacturer, NeoMed, Inc., or its contracted labs.
• Retrospective or Prospective: N/A for this type of bench/functional testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This document describes bench and biocompatibility testing for a medical device (an extension set), not a diagnostic or prognostic device that requires expert-established ground truth from patient data. The "ground truth" for these tests would be the established engineering standards or regulatory requirements.

4. Adjudication method for the test set

• Not Applicable. As above, this is laboratory and bench testing, not a clinical study involving human readers or subjective interpretations requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No such study was done. This device is an enteral extension set, a physical medical device, not an AI-powered diagnostic or decision support system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Engineering Standards and Regulatory Guidelines. For the functional and biocompatibility tests, the "ground truth" is adherence to established industry standards (e.g., ISO 10993-1 for biocompatibility) and the device's design specifications.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this device does not involve machine learning or AI.

9. How the ground truth for the training set was established

• Not Applicable. As above, no training set.

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The Enteral Only Extension Set is intended for use as an extension set for nasogastric/oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors which reduce the risk of accidental connection of an I.V. system to the enteral system, or the enteral system to an I.V. system.

The Enteral Only Extension Set consists of flexible PVC tubing designed to connect existing feeding tubes (nasogastric, gastric, etc.) to various delivery systems including pumps and syringes. The basic set consists of tubing with an enteral connector (catheter tip) and either a luer lock connector or an oral syringe connector. Other variations include the basic sets with the addition of a stop cock or Y site, to allow the clinician to attach other equipment. One configuration (Model 95017-D) utilizes luer lock connections on either end of the extension set, to allow for the connection to existing enteral feeding tubes with luer fittings. Note that in this configuration set does not utilize an oral syringe connection, to minimize the possibility of oral feeding solutions to be delivered into an IV line.

The provided text describes a medical device, the "Enteral Only Extension Set," and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria in the context of device performance metrics like accuracy, sensitivity, or specificity.

Instead, the document details a 510(k) submission for regulatory clearance, which focuses on demonstrating substantial equivalence to already legally marketed predicate devices. The "study" mentioned refers to "Design verification tests" which were performed to ensure the device met "required acceptance criteria," but these acceptance criteria are not explicitly defined in terms of specific performance outcomes to be measured.

Here's a breakdown of what is and is not present based on your request:

1. Table of acceptance criteria and the reported device performance:

• Not Available: The document states, "All tests were verified to meet the required acceptance criteria," but it does not specify what those acceptance criteria were (e.g., minimum tensile strength, flow rate) nor does it provide a table of the reported numerical performance data from these tests. The tests are general "Design verification tests" resulting from risk analysis and product requirements, rather than a clinical or performance study with defined metrics.

2. Sample size used for the test set and the data provenance:

• Not Applicable/Not Available: This type of information (sample size, country of origin, retrospective/prospective) is typically associated with clinical or performance studies evaluating diagnostic or therapeutic efficacy, which is not what this document describes. The verification tests performed were likely engineering/design tests, not studies on a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable/Not Available: Ground truth, experts, and their qualifications are relevant to studies where the device's output (e.g., a diagnosis, a measurement) is compared against a definitive standard. This document focuses on the design and manufacturing of an extension set, not on its diagnostic or therapeutic outcome.

4. Adjudication method for the test set:

• Not Applicable/Not Available: Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or subjective assessments to establish consensus, which is not relevant to this device's verification.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable/Not Available: This device is an enteral feeding extension set, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI-assisted performance improvements are not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not Applicable/Not Available: As above, this is not an AI algorithm.

7. The type of ground truth used:

• Not Applicable/Not Available: Because this is a physical medical device (an extension set) and not a diagnostic or AI-driven tool, the concept of "ground truth" (expert consensus, pathology, outcomes data) as typically applied to performance studies does not directly apply to its design verification. The "ground truth" for the verification tests would be defined engineering specifications and functional requirements.

8. The sample size for the training set:

• Not Applicable/Not Available: The term "training set" is used for machine learning or AI models. This device is a physical product, not an AI system.

9. How the ground truth for the training set was established:

• Not Applicable/Not Available: See point 8.

In summary:

The provided text from the 510(k) submission describes a design verification process rather than a clinical performance study with specific acceptance criteria related to diagnostic accuracy or clinical outcomes. The "acceptance criteria" referred to are likely engineering and functional specifications for the physical device, which were "met" during the design verification tests. The document aims to establish substantial equivalence to predicate devices based on design and material properties, not on comparative performance metrics in a clinical setting.

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